Evaluation of Marginal, Internal Adaptation and Clinical Performance of Endo-crowns Fabricated From Nano Hybrid and Lithium Di-silicate Ceramic Materials.

NCT ID: NCT04737005

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-03-01

Brief Summary

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

Detailed Description

Evaluation of the marginal and internal adaptation using silicon replica technique, which will be measured by digital microscope and clinical Performance using modified USPHS scoring system of Endo-crowns fabricated from Nano-ceramic Hybrid and Lithium di-silicate ceramic materials.

Primary outcome: Marginal gap of the two groups will be measured using Silicon replica technique, Each replica will be sectioned bucco-lingually and mesio-distally into four segments named (MB, DB, ML, DL) and each segment has five reference points assigned at different positions, An overall of twenty reference points will be measured in each replica sample using a digital microscope.

Secondary outcome:

• Internal gap of the two groups will be measured using Silicon replica technique, which will be measured by digital microscope.
• Clinical Performance of the two groups will be evaluated using modified USPHS scoring system. (Color match, Marginal discoloration, Surface texture and Gross fracture)

Conditions

Clinical Fit and Clinical Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nano-ceramic hybrid (Grandio Blocs) Endo-crown.

Nano-ceramic hybrid ( intervention)

Group Type: OTHER

Nano-ceramic hybrid (Grandio Blocs) Endo-crown

Intervention Type: PROCEDURE

Nano-ceramic hybrid

Lithium di-silicate Ceramic (E.max CAD blocks) Endo-crown

Lithium di-silicate Ceramic ( Control)

Group Type: ACTIVE_COMPARATOR

Nano-ceramic hybrid (Grandio Blocs) Endo-crown

Intervention Type: PROCEDURE

Nano-ceramic hybrid

Interventions

Nano-ceramic hybrid (Grandio Blocs) Endo-crown

Nano-ceramic hybrid

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• From 18-50 years old, be able to read and sign the informed consent document.
• Have no active periodontal or pulpal diseases, have teeth with good restorations.
• Psychologically and physically able to withstand conventional dental procedures.
• Patients planned for a single coverage restoration in the posterior area.
• Able to return for follow-up examinations and evaluation.
• Patients have root apex of molar without evident damage and no root fracture.
• Good oral hygiene habits.
• Have a complete root canal therapy molar necessitating an Endo-crown restoration.

Exclusion Criteria

• Patient less than 18 or more than 50 years
• Patients with severe clenching or bruxism.
• Patient with active resistant periodontal diseases
• Patients with poor oral hygiene and uncooperative patients
• Pregnant women
• Patients in the growth stage with partially erupted teeth
• Psychiatric problems or unrealistic expectations
• Patients with inadequate or low quality endodontic treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mai Salahel-din Abdel-azim

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

191020

Identifier Type: -

Identifier Source: org_study_id